Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Job Description

We are seeking a dedicated and focused Quality Assurance Specialist to join our team in processing pharmaceutical, medical device, and combination product complaints and inquiries. This role offers an excellent opportunity for cross-functional exposure and interaction with lab personnel, ensuring compliance with global regulatory requirements.

Responsibilities

• Ensure complaint records meet global regulatory requirements.
• Perform product complaint documentation, investigation, and review of all non-medical complaint content.
• Review medical complaints involving non-medical quality issues.
• Provide quality customer service, including coordinating return samples and arranging product replacements.
• Ensure documentation meets Good Documentation Practices, GMP, and GCP standards.
• Maintain complaint files that meet all regulatory expectations.
• Identify potentially reportable events and notify appropriate functional groups and management.
• Interface with healthcare professionals, the general public, internal teams, and regulatory agencies.

Essential Skills

• Bachelor’s Degree in a relevant field of study.
• Educational or work experience in the pharmaceutical or product complaint space.
• Strong critical thinking, critical reading, and clear communication skills.
• Proficiency with Microsoft Office (Outlook, Excel, Teams, PowerPoint, Word).
• Ability to focus, prioritize tasks, and manage workload effectively.

Additional Skills & Qualifications

• Bachelor’s Degree required; preferred degrees include technology or scientific backgrounds (MLT, LPN, RN).
• 0–3 years of experience in a cGMP-related industry or clinical setting preferred.
• Knowledge of global regulatory requirements for pharmaceuticals, medical devices, and combination products.
• Familiarity with FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, 211) preferred.
• Ability to prioritize multiple projects while ensuring compliance with SOPs and regulations.
• Strong written and verbal communication skills.
• Experience using computer systems for word processing and complaint management.
• Ability to work effectively with cross-functional teams, peers, management, and customers.

This is a Contract position based out of Grayslake, IL.

The pay range for this position is $23.00 - $26.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Grayslake,IL.

This position is anticipated to close on Apr 20, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $23 - $26